Canagliflozin-Mealtime Insulin Rescue

Foundation for Atlanta Veterans Education and Research, Inc.

Status and phase

Active, not recruiting

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: canagliflozin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02624908

28431754DIA4008

Details and patient eligibility

About

24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.

Full description

The Canagliflozin Mealtime Insulin Rescue study will enroll up to 40 subjects at the Atlanta VA Medical Center. Subjects will be screened and enter a 2-week run-in period during which they will switch to or continue on a diabetes treatment regimen of basal insulin before supper and aspart insulin before meals. Run-in will be useful in evaluating compliance to treatment and self-monitoring. After run-in, subjects will collect one week of baseline glycemic data with regular pre-meal and fasting glycemic levels using both finger stick testing and continuous glucose monitoring.

Subjects will be randomized at Visit 3 to 100 mg of canagliflozin or placebo. If well tolerated, this dose will be increased to 300 mg of canagliflozin or placebo at Visit 4.

Diabetes management will be assured through regular contact with the study team (weekly calls and clinic visits at Weeks 4, 8, 16 and 24). Management will be facilitated by diabetes management software. Self-monitoring and continuous glucose monitoring will be repeated at the end of study participation.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

use of basal-bolus insulin
onset of diabetes after age 30
BMI less than 35
eGFR at least 60 ml/mn
Hb A1c 7.0-10.0%
willingness to perform home glucose monitoring
willingness to transmit glucose and medication information weekly

Exclusion criteria

Type 1 diabetes
Known peripheral artery disease
Liver enzymes equal or more than 1.5 times the upper limit of normal
Chronic heart failure NYHA class III or IV
Current haemodialysis or peritoneal dialysis
End stage liver disease, defined as acute or chronic liver disease and recent history of one of the following: ascites, encephalopathy, variceal bleeding, bilirubin equal or greater than 2.0 mg/dL, albumin equal or less than 3.5 g/ dL, prothrombin time greater or equal to 4 seconds, INR greater than or equal to 1.7 or prior liver transplant
Known or suspected hypersensitivity to trial products or related products
Female of child-bearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods as required by law or local practice.
Expected simultaneous participation in any other clinical trial of an investigational medicinal product.
Receipt of any investigational medicinal product within 30 days before randomization
Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Any condition that in the investigator's opinion would make the subject unable to adhere to the trial visit schedule and procedures
Known history of non-compliance to treatment.